New options for medicine and medical equipment industry
Marketing supervisor general・Quality assurance manager・Safety supervisor
A consulting firm that supports all 3 tasks
Consulting Service
Post-Marketing Pharmaceutical Service
Safety Management Service
OUR BUSINESS
Support resolving company’s problems
with broad services
Offering various services
mainly from consulting.
By using our strength of getting three key roles done in one-stop,
we will guide to resolve problems.
Consulting
Construct work analysis and operational improvement for safety management operation efficiency
Advise and interview support for responding inquiry matters to authorities
Support obtaining and renewing the authorization of manufacturing and distribution
Prepare various SOP
Construct CTD2.7 and package insert draft
Others
Safety Management
Accept whole medicine and medical device’s safety management operation
Collect, analyze and measure safety management information (adverse event)
Safety evaluation using our own Safety database Arisglobal (after clinical trials and post marketing)
Construct forms such as RMP, PBRER, DSUR, unknown non-serious regular case report and infectious disease regular report
Post-Marketing Pharmaceutical
Construct package insert and related documents
Correspond inquiry matters from authorities
CMC pharmaceutical operation
Support certificate of approval
Support drug price calculation process
REASON
Why it is chosen
CUES Consulting INC. will support and carry out quality control・safety management operation which are essential for manufacturing and distributing the medicine and medical equipment.
We are also capable of assisting overall operations including marketing supervisor general tasks.
CUES
is chosen
Reason
Assisting entire
3 manufacturing roles
1Assisting entire 3 manufacturing roles
We will assist the three operation roles, Marketing supervisor general・Quality assurance manager・Safety supervisor. This is a new service that was never before covering everything from establishing venture companies to safety management after marketing. We will assist from everything.
Highly
specialized staff
High cost
performance
Global standard
quality
FLOW
Operational flow
Operation term
From inquiry to estimation
⇒ about 1 week
• When consulting/ creating application form etc.
⇒ Earliest as 1 week~ after agreement
• When using data base
⇒ Earliest as 3 months ~
01
Inquiry
AContact us from the inquiry form by phone.
02
Reviewing
APerson in charge will contact you and review your current situation and requests.
03
Proposal・Estimation
AWe will propose the estimation and the best plan from reviewing the customer’s needs.
04
Contract・Place an order
BWe will sign a contract necessary for placing the order such as non-disclosure agreement.
05
Offering services
BWe will operate the services discussed in the proposal.
06
Confirmation・Delivery
Please confirm the final products.
It will be delivered after any modification.
07
Payment
We will close at the end of delivered month and issue the invoice. Please pay by the end of the following month.
CORPORATE POLICY
Providing low-cost and the Global Head Office
standard quality
CUES Consulting INC. was founded to improve our client’s operation and from the spirit of “Constructing a structure that can provide proper resources and advanced knowledge.”
Medicine and medical equipment are increasingly demanded from the regulatory authority.
Whereas for a startup company or a company whose supplies are limited, are having difficulties trying to meet the compliance that’s been rising each year and with just small staff members covering broad tasks.
I have worked at the mega pharma to operate security management for many years. After this, I transferred to a smaller pharmaceutical company as a safety manager and struggled with a dilemma of not having enough resources and operation improvements progressing in a slow speed.
With these experiences, CUES Consulting INC. was founded with the attention to establish a structure that can provide proper resources and advanced knowledge even for smaller companies. With having organized mainly with experienced medicine’s marketing supervisor generals and safety supervisors, our mission is to provide services with a reasonable price from clinical trials to marketing, overall support of three key roles including generalization and improving compliance and operation for small medicine・medical equipment companies.
Furthermore, our specialties are to suggest proposals for efficient management operations, negotiate with authorities and Global Head office and pharmaceutical works from our experiences.
CUES Consulting INC. will continue to seek for limitless possibilities.
Representative Director
Motoyuki Takano
COMPANY PROFILE
Aiming to become the best partner for medicine and medical equipment manufacturer
With high expertise, the experienced Marketing supervisor general
・Safety supervisor staff will answer all the diverse requests and reduce customer’s operation.
| Company Name | CUES Consulting INC. |
|---|---|
| Representative | Motoyuki TAKANO |
| Employees | 10 |
| Address | 9-3 Nibancho, Chiyodaku, Tokyo 102-0084 |
| Tel | 03-6803-6361 |
| URL | https://cues.or.jp/ |
| Our Services |
1.Consulting Service Construct work analysis and operational improvement for safety management operation efficiency Advise and interview support for responding inquiry matters to authorities Support obtaining and renewing the authorization of manufacturing and distribution Prepare various SOP Construct CTD2.7 and package insert draft Others 2.Safety Management Service Accept whole medicine and medical device’s safety management operation Collect, analyze and measure safety management information (adverse event) Safety evaluation using our own Safety database Arisglobal (after clinical trials and post marketing) Construct forms such as RMP, PBRER, DSUR, unknown non-serious regular case report and infectious disease regular report 3.Post-Marketing Pharmaceutical Service Construct package insert and related documents Correspond inquiry matters from authorities CMC pharmaceutical operation Support certificate of approval Support drug price calculation process |
| Clients | Major foreign affiliated medicine manufacture, Major domestic medicine manufacture, Medical equipment manufacture |
| Main Bank | Tokyo Mitsubishi UFJ, Sumitomo Mitsui, Mizuho |
| Access | By train transportation: 1 minute walk from Tokyo Metro Yurakcho Line “Kojimachi Station” |
PRIVACY POLICY
CUES INCORPORATED (hereinafter referred to as “we” or “our”) will provide and disclose the Personal Information Protection Policy and promote protection of personal information by having all employees as well as our concerned personal follow and understand the importance of the Personal Information Protection Policy.
Proper collection of personal informationWe will collect personal information with a proper procedure and will announce or notify the purpose of use clearly in advance.
Purpose of using personal informationWe will use the personal information that are collected from customers only for contacting, introducing the business and documents, responding to the questions and informing the seminar by sending emails and mails.
Prohibition of disclosure and provision of personal information to third partiesWe will properly manage all personal information and will not disclose to any third parties except in one of the following cases.
1-When agreed by the customer.
2-When we outsource the business to the concerned personal to proceed the customer’s request and when required to disclose by the law.
3-When requested from public institutions such as the court, public prosecutor’s office and any law enforcement agencies by statue.
4-When a government or local organization, or an entrusted personal are needed for cooperation in order to proceed the affairs prescribed by law and regulations and when it is recognized that obtaining the person’s consent on the submission of personal data by cooperating government or local organization, or an entrusted personal are likely to impede the execution of the affairs concerned.
5-When especially needed for improving public hygiene or promoting children’s healthy development and when difficult to obtain the personal’s agreement.
6-When the customer or the third party’s life, body, property and reputation are in risk and when we cannot obtain the personal’s agreement.
7-When our rights, properties or services are needed protection or defense from the violation act of the law or our user policy and precautions and when we cannot obtain the personal’s agreement.
8-When provision of personal information is needed for combined, succession or joint ownership of the business in any reasons.
Management of personal informationWe will maintain the personal information accurately and most up-to-date and to prevent personal information’s unauthorize access, loss, damage, manipulation and leakage, we will take necessary security measures such as to sustain security systems, develop management system and thoroughly train employees to strictly manage personal information.
Security measures of personal informationWe are implementing all possible security measures to insure the personal information’s accuracy and safety.
Request of personal’s disclosureWhen the customer request to disclose, revise, suspend the use, or delete their personal information, we will proceed with confirming the subject.
Review and comply the law and normWe will obey any law or other norms regarding the retaining personal information and appropriately review and improve this policy’s contents.
Release and RevisionWe will indicate the release start date using A.D., descript the public announcement date and make sure to date the revised date clearly.
About cookiesOur website uses cookies. Cookie is the user’s information data stored inside the user’s hard disk. The cookie used for our website does not connect with the personal specification information. The website can be used without an issue when rejecting the use of the cookie.
About logfileWe adopt logfile to manage the website, analyze the tendency of use, detect the user trend and to obtain congregative and broad demography information. The information gathered from logfile are not connected to the personal specification information.
About link with other websitesOur website includes links to other website, but it will not share any personal information. Please refer to the link website for handling personal information. We will not take any responsibility regarding the website’s contents.
ContactFor inquiries regarding the handling of personal information, contact us using the information below.
CUES INCORPORATED
9-3 Nibancho, Chiyodaku, Tokyo 102-0084
Tel：03-6803-6361 (Representative)（代表）
E-mail：cues.jp@gmail.com
Enactment date：
October 22, 2020
CUES INCORPORATED
Representative Director Motoyuki Takano